New York-based Ventrus Biosciences ($VTUS) put out the word this morning that its experimental therapy for hemorrhoidal disease failed to beat a placebo for the primary and secondary endpoints in a late-stage study. The data were so bad, the company opted to tank the whole program. And the biotech's share price was clobbered, with the stock plummeting more than 60%.
Ventrus recruited more than 600 patients for the late-stage study of iferanserin (VEN 309). Investigators had hoped to see some significant improvements in stopping bleeding as well as stopping itching and pain in 7 to 14 days after beginning therapy. But without a win in Phase III, Ventrus is trying to change the story line, regrouping and refocusing its attention on the new drug application planned for diltiazem (VEN 307).
"Despite this setback, we remain excited about our pipeline and, with a strong cash position, plan to refocus our efforts on taking VEN 307 forward toward registration as a treatment for anal fissures," said Ventrus CEO Russell H. Ellison in a release. "VEN 307 recently demonstrated a positive outcome in all key measures of efficacy--pain on defecation, overall pain and healing--in this indication in its first Phase 3 study. With the planned elimination of all VEN 309-related expenses, we believe the Company is sufficiently capitalized to take VEN 307 through a second Phase 3 study and to approval."
Ventrus's pipeline includes VEN 308 for fecal incontinence. "In addition to VEN 307, we look forward to beginning the advancement of our VEN 308 program, as we believe an aging population and increase in gastroenterologic procedures has created a heightened demand for new and better options in managing fecal incontinence," Ellison added.
- here's the press release